Grand Pharmaceutical (00512.HK) Announces Global Innovative Corticosteroid Nanosuspension Ophthalmic Drop Successfully Met Primary Endpoints in Overseas Phase III Clinical Trials

Grand Pharmaceutical(00512) announced that its partner in the ophthalmology field, Formosa Pharmaceuticals, has successfully reached the clinical endpoints in the Phase II clinical trial and two Phase III clinical trials conducted in the United States for its hormone nanosuspension eye drop, APP13007, used for anti-inflammatory and analgesic purposes. According to clinical results, APP13007 demonstrated significant efficacy in treating post-operative ocular inflammation and pain, with a favorable safety profile. A New Drug Application (NDA) is planned to be submitted to the U.S. Food and Drug Administration (FDA) in the first half of this year. Grand Pharmaceutical Group Limited holds the exclusive rights for the development and commercialization of this product in mainland China, Hong Kong, and Macao.

APP13007 is an anti-inflammatory and analgesic hormone nano-suspension eye drop. Its unique nano-formulation technology effectively addresses the low bioavailability and safety risks caused by the poor water solubility of hormone products. The Phase II clinical trial (CPN-201) and two Phase III clinical trials (CPN-301 and CPN-302) conducted in the United States for APP13007 all adopted a randomized, double-blind, placebo-controlled design, enrolling nearly 900 patients who underwent cataract surgery. The primary clinical endpoint was to evaluate the proportion of subjects with complete resolution of post-cataract surgery ocular inflammation and complete pain relief without recurrence. Based on the comprehensive statistical analysis of the three clinical studies, in terms of safety, the treatment group and the control group showed comparable results, with subjects tolerating APP13007 well. Regarding anti-inflammatory effects, after 14 days of continuous dosing, the proportion of subjects with zero anterior chamber cell count (an inflammation indicator) was 58.2% vs 17.3% in the treatment group versus the control group. In terms of analgesia, the proportion of subjects reporting a pain index of zero on Day 4 was 81.4% vs 47.4%, and in terms of sustained efficacy, the proportion of subjects maintaining a pain index of zero from Day 4 to Day 15 was 71.6% vs 27.7%. Overall, the analysis shows that APP13007 demonstrated significantly superior efficacy in treating post-cataract surgery inflammation and pain compared to the control group, with good safety. Additionally, regarding registration in China, Grand Pharmaceutical Group Limited submitted a new drug clinical trial (IND) application for GPN00833 (APP13007) to the National Medical Products Administration (NMPA) in January this year, which has been accepted.

Hormonal ophthalmic preparations are one of the most commonly used and effective drugs for treating ocular inflammatory reactions, capable of rapidly and effectively controlling post-operative inflammation and conditions in ophthalmology. However, due to limitations in ophthalmic preparation technologies, currently, China's hormonal ophthalmic preparations market is dominated by imported products. In the past decade, no new products have entered this niche market. Clinically, there is an urgent need for potent steroid eye drops with high safety. The APP13007 product is expected to meet this clinical demand.

As one of the leading comprehensive enterprises in China specializing in the research, production, and sales of ophthalmic drugs, the Group boasts nearly 30 ophthalmic products currently on the market. These products primarily focus on mainstream indications such as dry eye syndrome, fundus hemorrhage, glaucoma, cataracts, anti-inflammatory treatments, and myopia-related conditions. The product range covers chemical preparations, traditional Chinese medicine formulations, and ocular health products, including prescription drugs, OTC medications, medical devices, and consumer goods. Together, these form an integrated "public eye care ecosystem" that combines "prevention + treatment + health maintenance." In terms of innovative R&D, the company has a pipeline of globally innovative products targeting "myopia," "dry eye syndrome," "pterygium," and "post-operative anti-inflammatory and analgesic treatments for ophthalmic surgeries." Among them, the innovative pterygium treatment CBT-001 was approved in March this year to commence Phase III clinical trials in China, while the small-molecule peptide drug GPN00136 (BRM421) for dry eye syndrome submitted its IND application to the regulatory authority in January and received acceptance. Moving forward, this division will adhere to the development strategy of "leading with innovative blockbuster drugs and devices, supported by products from the public eye care ecosystem," continuously strengthening industry influence and achieving new breakthroughs in business domains.